1Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Inspection Record
Catalent Pharma Solutions, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
3Laboratory and QC controls
Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
4Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
5Process validation
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
7Other quality system
DEP ART!\fi:NT OF HEALTH AND HUMAi'l SERVICES DISTRICT ADDRESS AND PHONE NUMBER 555 Winder ly Place , Suite 200 3/14/2016- 3/25/2016* Maitland, FL 32751 FEJNUMBER (407) 475-4700 Fax: (407) 475-4768 1811396 NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED Dina Kostakis ' General...
8Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
9Process validation
There are no written procedures for production and process controls designed to assume that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
10Material and supplier control
Component weighing operations are not adequately supervised.
11Equipment and facility
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
12Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
13Complaint and recall handling
An NDA-Field Alert Report was not submitted within REDACTED B4 of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
14Other quality system
Written procedures have not been developed for the receipt and evaluation of post marketing adverse drug experiences.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
